Superficial Cervical Plexus Versus Retrolaminar Block in Parotid Surgeries

Supportive Care Clinical Trial

Official title:

Efficacy of Superficial Cervical Plexus Block Versus Cervical Retrolaminar Block Both Combined With Auriculotemporal Nerve Block in Parotid Surgeries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04138147
• Other study ID #: MD/19.03.162
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2019
• Est. completion date: December 2020

Study information

• Verified date: September 2020
• Source: Mansoura University
• Contact: Ghada S Mohammed, Master
• Phone: 00201090085600
• Email: dr_adamghada[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The parotid gland receives sensory and autonomic innervation. Sensory innervation is supplied by the auriculotemporal nerve (gland) and the great auricular nerve (fascia). The parasympathetic innervation to the parotid gland begins with the glossopharyngeal nerve. This nerve synapses with the otic ganglion. The auriculotemporal nerve then carries parasympathetic fibers from the otic ganglion to the parotid gland. Parasympathetic stimulation increase saliva production. Sympathetic innervation from the superior cervical ganglion, part of the paravertebral chain

Description:

Detailed Description:

The aim of this study will be comparing efficacy of superficial cervical plexus block with cervical retro laminar block both combined with auriculotemporal nerve block in parotid surgeries.

Technique of ultrasound guided auriculotemporal nerve block:

The patient will be placed in a supine position with each side facing up. The temporomandibular joint will be identified after palpitation. A high frequency linear ultrasound transducer (7-12 megahertz) will be attached to ultrasound machine (SIEMENS ACUSON P300, Germany) will be placed between the tragus and temporomandibular joint. Color Doppler imaging will be used to identify the superficial temporal artery. The injection needle will be inserted anterior to the tragus posterior to the temporal artery (out-of-plane approach) 1 to 1.5 cm till reaching the periosteum. The reason of out-of-plane approach is that the superficial temporal artery is in the needle entry of in-plane procedure during auriculo-temporal nerve block. Following negative aspiration local anesthetic will be injected in fractionated doses following intermittent aspiration.

Technique of ultrasound guided superficial cervical plexus block:

Standard precautions for the ultrasound guided nerve blocks performance will be done which include standard monitoring, the skin overlying the injection site will be free of signs of infection and after proper skin sterilization with an antiseptic solution and the probe surface in contact with the skin will be covered with a sterile adhesive dressing Patients will be in the supine position with the head turned slightly away from the side to be blocked to facilitate operator access. The anesthesiologist will be at the patient's side at the level of the shoulder. Posterior in-plane approach to the superficial cervical plexus block will be done. In this approach, a high-frequency linear transducer (7-12 Megahertz) will be attached to ultrasound machine (SIEMENS ACUSON P300), the transducer will be placed in a transverse orientation across the neck with the probe marker facing medial (toward the thyroid cartilage). A 22-gauge needle will then be inserted at the posterior border of the sternocleidomastoid muscle at the level of the cricoid cartilage and advanced underneath the muscle belly toward the carotid artery. The needle tip will be positioned to inject local anesthetic deep to the sternocleidomastoid muscle along its tapering posterolateral border but superficial to the prevertebral fascia. Deeper injection should be avoided because it can result in a deep cervical plexus block. As much as 10 ml of local anesthetic will be used for this block.

Technique of ultrasound guided cervical retrolaminar block:

The patients will be in the lateral position. Patient neck will be slightly flexed forward, the anesthesiologist will stand behind the patient. Firstly, landmark will be the identification of cervical vertebrae number 7 as it is the largest and most prominent spinous process by palpation in axial plane. Then the high-frequency linear transducer (7-12 Megahertz) which attach to ultrasound machine (SIEMENS ACUSON P300), Ultrasound scanning will be performed while the probe in transverse position in the mid sagittal plane of cervical vertebrae number 7 spinous process. Then counting up the spinous processes till reaching the spinous process of cervical vertebrae number 4 and then the probe will be moved laterally 1 cm to image the left or right muscles. Identification of the echogenic (bright, reflective) laminae will be seen, above it muscles will be imaged. The splenius capitis lies deep to the trapezius and is a broad, flat muscle. The semispinalis capitis will be easily recognized as a long, strap-like muscle divided into 2 sections by an aponeurotic intersection. The deep neck muscle group has a distinctive tear drop shape (semispinalis cervicis, multifidus, and rotatores).

An in-plane approach by using a 22 gauge, 50 mm, echogenic needle. The needle will be introduced to reach the lamina. After negative aspiration the local anesthetic will be injected through the needle under real-time ultrasound visualization. The criteria for assessment of correct spread of the injectate will creating a plane/hypo-echoic.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists physical status grade I and grade II.

• Elective parotid surgery.

Exclusion Criteria:

• Patient refusal.

• Coagulopathy.

• Psychiatric diseases.

• Local skin infection and sepsis at site of the block.

• Known intolerance to the study drugs.

• Body Mass Index > 40 Kg/m2.

• Central or peripheral neurological disease.

• Previous neck surgery.

Related Conditions & MeSH terms

• Supportive Care

Intervention

Procedure:
• Superficial cervical plexus with auriculotemporal nerve blocks
Superficial cervical plexus block using 10 ml bupivacaine 0.5%. Auriculotemporal nerve block using 3 ml bupivacaine 0.5%.
• Cervical retrolaminar with auriculotemporal nerve blocks
Cervical retrolaminar block using 10 ml bupivacaine 0.5%. Auriculotemporal nerve block using 3 ml bupivacaine 0.5%.

Locations

Country	Name	City	State
Egypt	Oncology Center, Mansoura University (OCMU)	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time of first analgesic request post-operative.	The time of first analgesic request in hours.	24 hours postoperative.
Secondary	Total post-operative opioid requirement.	Total post-operative morphine requirement in milligrams..	24 hours postoperative.
Secondary	The number of patients required rescue post-operative opioid analgesia..	in number.	24 hours postoperative.
Secondary	Post-operative pain scale.	by Visual analogue scale (VAS): (where 0 means no pain- while 100 mm is the worst pain) at 0, 1, 2, 6, 12 and 24 hours.	24 hours postoperative.
Secondary	Intra-operative fentanyl consumption.	in micro grams.	Intraoperative (2 hours).
Secondary	Heart rate (HR).	in beat/minutes, recorded basal, intraoperative: after the block 15 min and 30 min then every 30 minutes till the end of surgery, then postoperative at 0, 1, 2, 6, 12 and 24 hours.	Intraoperative (2 hours), postoperative for 24 hours.
Secondary	Mean arterial blood pressure (MAP).	Non invasive mean arterial pressure, in mmHg, recorded intraoperative: basal, after the block at 15 min and 30 min then every 30 minutes till the end of surgery, then postoperative at 0, 1, 2, 6, 12 and 24 hours.	Intraoperative (2 hours), postoperative for 24 hours.
Secondary	Intra-operative atracurium consumption	in milligrams.	Intraoperative (2 hours).
Secondary	The concentration of isoflurane.	in percent, recorded after the block every 30 minutes till the end of surgery.	Intraoperative (2 hours).
Secondary	Sensory block assessment.	Define the number of blocked dermatomes at post anesthesia care unit by skin pinprick. sensation at dermatomal distribution.	1 hour post-operative.
Secondary	The block procedural duration.	In minutes.	30 minutes.
Secondary	Post-operative complication rate (nausea, vomiting and headache)	In number.	24 hours postoperative.
Secondary	Assessment of diaphragmatic dysfunction.	Using ultrasound assessment,	1 hour postoperative.